BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 15624536 · Received October 18, 2022

    Report

    Report Number
    1314492-2022-04424
    Event Type
    Injury
    Date Received
    October 18, 2022
    Date of Event
    September 16, 2022
    Report Date
    November 22, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412498683
    PMA / PMN Number
    K133801
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION. DURING FUNCTIONAL TESTING, THE DEVICE WAS TESTED FOR FLOW ACCURACY AND WAS FOUND TO DELIVER WITHIN RANGE AND A FALSE UPSTREAM OCCLUSION ALARM DID NOT OCCUR DURING THE TEST. A REVIEW OF THE EVENT HISTORY LOG REVEALED UPSTREAM OCCLUSION MESSAGES. THE HISTORY LOG CANNOT BE USED TO DETERMINE IF THE ALARMS WERE TRUE OR FALSE. A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE REPORTED CONDITION WAS NOT VERIFIED. THERE IS CURRENTLY AN OPEN FIELD ACTION (FA-2021-056) ASSOCIATED WITH REINFORCING PROPER IV LINE SETUP TO PREVENT PARTIAL OR FULL OCCLUSIONS, AND DETECTION OF UPSTREAM OCCLUSION FOR SPECTRUM PUMPS, WHICH CAN LEAD TO UNDER-INFUSIONS. IF THE USER DOES NOT FULLY ADDRESS AN UPSTREAM OCCLUSION BEFORE RESTARTING THE INFUSION, THE PUMP'S ABILITY TO DETECT AN UPSTREAM OCCLUSION MAY BE REDUCED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SPECTRUM PUMP UNDERINFUSED DURING NOREPINEPHRINE TREATMENT IN THE INTENSIVE CARE UNIT. THE PUMP GENERATED UPSTREAM OCCLUSION ALARMS. THE CLINICIANS CONTINUED TO TITRATE UP BUT DID NOT SEE ANY RESPONSE WITH THE PATIENT'S BLOOD PRESSURE. THE VOLUME IN THE BAG WAS NOT CHANGING SO THE SPECTRUM PUMP WAS SWITCHED WITH ANOTHER SPECTRUM PUMP WITH THE ORIGINAL TUBING. THE PATIENT'S BLOOD PRESSURE "SHOT UP" WITH THE NEW PUMP AND THEY WERE ABLE TO TITRATE THE NOREPINEPHRINE DOWN. THE PATIENT WAS DISCHARGED FROM HOSPITAL ON THE SAME DAY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2481956 SPECTRUM INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA 00085412498683

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention NOREPINEPHRINE